With more than two million page views and more than 4,500 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency, officially known as the California Institute for Regenerative Medicine(CIRM). David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.

Monday, September 12, 2016

The FDA's two-day hearing into stem cell treatments is underway this morning and can be seen live on the Internet, including a presentation this afternoon by the California stem cell agency, which is seeking to ease FDA regulation of stem cell clinical trials.

A likely preview of the comments from the agency popped up this morning on California Healthline in a piece by Emily Bazar. She carried the brief text of an interview with Randy Mills, president of the $3 billion California agency.

He said,

"The problem with (the FDA's current) strategy is twofold. It doesn’t address the
patients, or the need side of the equation. And I don’t think it has a
chance of actually working because the FDA will acknowledge that they do
not have the resources to enforce these types of regulations at the
clinic level.

"They would have to be essentially regulating the practice of
physicians, which is well beyond their capabilities. Even if they were
able to enforce it, it would just drive these patients somewhere else.

"We’re advocating for the creation of some middle pathway that would
bring essentially unregulated therapies into the regulatory fold, but in
a manner which could be complied with.

"I would rather know these clinics are being regulated and collecting
data than have them operating under the radar screen of the FDA. I would
like there to be a formal pre-market review of these therapies before
they’re put on the market. I would like there to be safety and efficacy
data.

"I’m going to try hard to get the FDA to see that just plugging this hole won’t make the problem go away."

Bazar's piece also contained the text of comments from Jeanne Loring, head of the stem cell research program at the Scripps Institute in La Jolla. She said,

"There’s no scientific evidence that the fat cells (unregulated) clinics are
using are going to do the patient any good. And there’s no evidence that
shows they are safe.

"I’m a stem cell scientist. I need scientific evidence before I will
believe anything. Regulation will help determine the efficacy and safety
of those fat cells.

"There are several lawsuits or potential lawsuits brewing over these
stem cell treatments. People were promised they would get improvements
and didn’t. And there are cases where people were actually harmed by
stem cells.

"Some people truly believe they have been helped by the stem cell
injections. I’m not going to argue with them. It’s a very personal and
emotional response. It’s not something that can be scientifically
validated. People are really desperate, especially really sick people
and their families.

"That means patients are at risk. That’s what bothers me a lot.
There’s nothing we can do to talk somebody out of going to a clinic if
they feel that’s the only option they have. We just want to make sure
nobody gets hurt. We also don’t want people to go broke. These
treatments are not covered by insurance and they cost tens of thousands
of dollars."

Here is a link to the actual broadcast, which is being watched by about 300 persons at this moment. An overview of the audience seems to indicate that it is being lightly attended. Mills is scheduled to speak at 4:23 p.m. EDT.

About Me

The California Stem Cell Report is the only nongovernmental website devoted solely to the $3 billion California stem cell agency. The report is published by David Jensen, who worked for 22 years for The Sacramento Bee in a variety of editing positions, including executive business editor and special projects editor. He was the primary editor on the 1992 Pulitzer Prize-winning series, "The Monkey Wars" by Deborah Blum, which dealt with opposition to research on primates. Jensen served as a press aide in the 1974 campaign and first administration of Gov. Jerry Brown. (Time served: two years and one week.) He writes from his sailboat on the west coast of Mexico with occasional visits to land. Jensen began writing about the stem cell agency in 2005, noting that it is an unprecedented effort that uniquely combines big science, big business, big academia, big politics, religion, ethics and morality as well as life and death. The California Stem Cell Report has been identified as one of the best stem cell sites on the Internet. Its readership includes the media (both mainstream and science), a wide range of academic/research institutions globally, the NIH and California policy makers.